Table 2 Application of MSC-based therapy in IBD clinical trials

Moderate to severe UC

Phase I/II randomized controlled study

Human umbilical cord

30/36 patients showed good response with markedly improved mucosa at 1 month

Decreased median Mayo score and histology score during follow up

No evident adverse reactions after MSC infusion

[53]

CD

Randomized controlled study

Human umbilical cord

Decreased CDAI, HBI, and corticosteroid dosage with remarkable mucosal recovery at 12 months

Concomitant anal fistula was improved in six patients treated with MSC

[54]

Luminal CD refractory to biologic therapy

Phase 2, open-label, multicenter study

Bone marrow

Improved recovery associated with reduced CDAI and CDEIS scores

7/15 patients had a clinical response, 8/15 had clinical remission, and 7/15 had endoscopic improvement

[55]

Complex perianal fistulas in CD

Phase 3 randomized double-blind controlled trial

Adipose

53/107 (50%) of MSC treated patients achieved combined remission in intention-to-treat protocol

53/103 (51%) of modified intention-to-treat populations achieved combined remission

[48]

UC

Two years observation after MSC treatment

Bone marrow

72.7% of UC patients who received MSC treatment achieved significant response

Reduced activity of autoimmune inflammation and stimulated reparative process in the intestinal mucosa

Increased duration of remission, reduced risk of recurrence of disease, and reduced frequency of hospitalizations

[56]

UC

–

Bone marrow

Increased in the duration of remission in patients with chronic recurrent and continuous recurrent course of UC

Reduced risk of relapse, and reduced frequency of hospital admissions compared with medication therapy

[57]

Crohn’s perianal fistula

MSC safety study in pregnancy

Adipose

Fertility and pregnancy outcomes were not affected by MSC treatment

No signs of treatment-related malformations were observed in the neonates by their respective pediatricians

[58]